Zevra Therapeutics, Inc. · NASDAQ:ZVRA
Zevra Therapeutics — Kempharm — Q3 2020 Earnings Presentation
14 slides from Zevra Therapeutics's earnings presentation, Oct 29, 2020
Slide 1: Q3 2020 Results
K Pharm Q3 2020 Results
Slide 2: Cautionary Note Regarding Presentation Information
Cautionary Note Regarding Presentation Information This presentation contains forward-looking statements, including statements regarding the potential approval timing for KP415, the potential label for KP415, the royalty or milestone payments under our license agreement with Gurnet Point Capital, th
Slide 3: Q3 2020 Results Call Participants
Q3 2020 Results Call Participants + Travis Mickle, Ph.D. - President & Chief Executive Officer + R. LaDuane Clifton, CPA — Chief Financial Officer, Secretary & Treasurer
Slide 4: KemPharm: Q3 2020 and Recent Highlights
KemPharm: Q3 2020 and Recent Highlights KP415 Updates - Held mid-cycle review meeting w/ FDA on Aug 13, affirmed PDUFA date of Mar 2, 2021, no safety issues raised at that time Late-cycle review meeting to be held ‘on Dec 1, if needed - Two additional U.S. patents governing SDX products issued, adds
Slide 5: KP415 Updates
KP415 Updates + Held KP415 NDA mid-cycle review meeting with FDA on Aug 13, 2020 o FDA re-affirmed KP415 PDUFA date of Mar 2, 2021, no substantive issues or safety concerns were raised o Late-cycle review meeting to be held on Dec 1, 2020 (if necessary) * Corium, Inc. is leading all commercial activ
Slide 6: Corium, Inc. - An Expanding Relationship
Corium, Inc. -An Expanding Relationship New consultation services agreement between KemPharm and Corium announced on Oct 5, 2020 o Agreement encompasses product development and regulatory activities for certain current and potential future products in Corium’s portfolio o New activities are above an
Slide 7: APADAZ — KVK-Tech/Sure Med Collaboration
APADAZ® — KVK-Tech/Sure Med Collaboration + Announced collaboration between KVK-Tech and Sure Med Compliance on Sep 10, 2020 o Newly announced program known as Perspectives in Care®, combines Sure Med’s opioid prescribing compliance tools with education and research to create a more-informed opioid
Slide 8: Special Meeting to Authorize Potential Reverse Stock Split
Special Meeting to Authorize Potential Reverse Stock Split + Special meeting of stockholders has been rescheduled for Nov 17, 2020 at 8:00 a.m. ET. + KemPharm is seeking authorization for a potential reverse stock split of the Company’s common stock; reverse stock split will only be made effective i
Slide 9: Special Meeting to Authorize Potential Reverse Stock Split
Special Meeting to Authorize Potential Reverse Stock Split Reverse split range between 1-for-3 and 1-for-40 intentionally broad o Itis impossible to predict at this time what ratio will be needed to reach a bid price of greater than $4.00; we will seek to optimize this ratio + The administrative pro
Slide 10: Q3 2020 Financial Results
Q3 2020 Financial Results + Revenue and Net Income (Loss) o Revenue of $1.9M, comprised of services revenue under the Corium consulting arrangement, compared to Q2 2020 service revenue of $1.9M o Q3 2020 is the fifth sequential quarter of services revenue o Net loss of ($3.0M), or ($0.04) per basic
Slide 11: Q3 2020 Balance Sheet Update
Q3 2020 Balance Sheet Update As of Sep 30, 2020, total cash’ was $5.5M, a decrease of $1.1M compared to Jun 30, 2020; forecasted cash burn rate of ~$1M/quarter o Based on operating forecast, expected revenues and existing resources, cash runway expected to up to the debt maturity date of Mar 31, 202
Slide 12: Next Steps on Improving Financial Position
Next Steps on Improving Financial Position + Phase 2 of debt restructuring remains one of our highest priorities; goal to complete prior to the KP415 PDUFA date + We continue to work with our financial advisors to determine the best pathway to restructure the debt and optimize the cost of capital/di
Slide 13: KemPharm: Next Steps and Outlook
KemPharm: Next Steps and Outlook KP415 NDA - FDAhas set KP415 PDUFA date of Mar 2, 2021 - KP415 Late-Cycle Review meeting with FDA scheduled for Dec 1, 2020, ifneeded KP415 approval milestones up to $48M Improved Financial Position - Based on current operating forecast, projected cash runway extends
Slide 14: Q3 2020 Results
K Pharm Q3 2020 Results